7 Monthly Screening LogTell us why patientswere not suitable
8 Monthly Screening LogComplete and sendto us in arrears
9 Screening Logs –why do them? Evidence of centre activityUseful for planning future studiesPrevents you missing suitable patients!Encourages you to think about STITCH (Trauma)Places the study in context of the general characteristics of patients treated in the study centres
11 How to randomise patients Items CoveredScreening logsHow to randomise patientsCT scansData collection formsAdditional forms
12 Check list for recruitment Does the patient meet the inclusion criteria?Check CT scan to confirm the diagnosis, size and location of the haematoma.- Correct any clotting or coagulation problems.- Check there are no exclusion criteria.2. Have you obtained informed consent?Information sheet .Time to ask questions.Written witnessed informed consent fromthe patient orthe person with the closest personal relationship with the patient who is themselves capable and willing to assent on behalf of the patient.Copies given to patient and filed in notes and site project file.3. Have you completed the randomisation form?
16 Web: https://viis.abdn.ac.uk/HSRU/stitch ORCall this number
17 The service will allocate: A randomisation numberThe treatment allocationWrite these on the form.Then return it to theSTITCH (Trauma) office.
18 Telephone Randomisation -Issues The randomisation service is independent (not STITCH)In case of problem, try both telephone and web services if possible.If you still have problems call the STICH Office on +44 (0)Outside normal office hours a message will give you our emergency number.
19 CT scans Items covered Screening logs How to randomise patients Data collection formsAdditional forms
20 The scans! Performed pre-randomisation & 5 day 2 different CDs - anonymised – DICOM formatForward on ASAP in case you lose access to them.
21 Data collection forms Items covered Screening logs CT scans How to randomise patientsData collection formsAdditional forms
22 Form types 14 day/ discharge form. 3 month questionnaire UK Only
23 Two Week / Discharge Form 8 page formStatus at time of completionMortality / Disability and GCSPrior to ICHPast medical historyInjury detailsAnticoagulant / antithrombotic treatmentTreatmentAny Surgery : Evacuation method, Neurological statusCrossovers?Daily for 5 days postGCS, limb disability, speech, pupils, temperature.ICP monitoringPost-randomisation events – eg stroke
24 Two Week / Discharge Form: common problemsEg Page 1Inconsistent detailsDates missing
28 What happens after 2 weeks? Non-UK The STITCH (Trauma) office will contact you at 4/5 and 10 months to confirm:Is the patient still aliveTheir addressAny major adverse eventsWe will ask you to draft a letter to the patient for us to send with the questionnaires.
29 What happens after 2 weeks? UK only The STITCH (Trauma) office will contact the patients GP at 2, 4/5 and 10 months to confirm:Is the patient still aliveTheir addressAny major adverse eventsWe will then draft a letter to the patient to accompany the questionnaires.
30 6 and 12 Month questionnaires The STITCH (Trauma) office will usually post these to patients.Postage is paid by the STITCH (Trauma) office.It is therefore essential that our investigators help to translate our questionnaires.
31 Your patientYou the investigatorUK Newcastle Office
32 Data Quality and payments All data forms and scans are checked when received by the STITCH (Trauma) OfficeQueries are sent viaOnce queries are resolved, payments are initiated!
33 Data Quality and payments Payment 1 = Randomisation form, CTs and 14 day/ discharge form.Payment 2 = Questionnaire and major adverse events form for 6 month (+ 3 month if in UK).Payment 3 = Questionnaire and major adverse events form for 12 month
34 Additional forms Items covered Screening logs CT scans How to randomise patientsData collection formsAdditional forms